Medical devices » Regulations » UNI EN 793



Italian norm
UNI EN ISO 11197
Publicated in:
1999-11
 

Title
Particular requirements for safety of medical supply units


CONTENTS

5- FOREWORD
6- INTRODUCTION

7- Section 1 GENERAL
7- SCOPE
7- NORMATIVE REFERENCES
8- TERMINOLOGY AND DEFINITIONS
9- GENERAL REQUIREMENTS AND REQUIREMENTS FOR TESTS
9- CLASSIFICATION
10- IDENTIFICATION, MAKING AND DOCUMENTS
15- POWER INPUT

16- Section 2 ENVIRONMENTAL CONDITIONS
16- BASIC SAFETY CATEGORIES
16- REMOVABLE PROTECTION MEANS
16- ENVIRONMENTAL CONDITIONS

17- Section 3 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17- GENERAL
17- REQUIREMENTS RELATED TO CLASSIFICATION
17- LIMITATION OF VOLTAGE AND/OR ENERGY
17- ENCLOSURES AND PROTECTIVE COVERS
17- SEPARATION
17- PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION
17- CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS
18- DIELECTRIC STRENGHT

19- Section 4 PROTECTION AGAINST MECHANICAL HAZARDS
19- MECHANICAL STRENGHT
19- MOVING PARTS
20- SURFACES, CORNERS AND EDGES
20- STABILITY IN NORMAL USE
20- EXPELLED PARTS
20- VIBRATION AND NOISE
20- PNEUMATIC AND HYDRAULIC POWER
20- SUSPENDED MASSES

21- Section 5 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
21- X RADIATION
21- ALPHA, BETA, GAMMA, NEUTRON RADIATION AND OTHER PARTICLE RADIATION
21- MICROWAVE RADIATION
21- LIGHT RADIATION (INCLUDING LASERS)
21- INFRA-RED RADIATION
21- ULTRAVIOLET RADIATION
21- ACOUSTICAL ENERGY
22- ELECTROMAGNETIC COMPATIBILITY

23- Section 6 PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
23- LOCATIONS AND BASIC REQUIREMENTS
23- MARKING, ACCOMPANYING DOCUMENTS
23- COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG EQUIPMENT
23- REQUIREMENTS AND TESTS FOR CATEGORY AP EQUIPMENT, PARTS AND COMPONENTS THEREOF
23- REQUIREMENTS AND TESTS FOR CATEGORY APG EQUIPMENT, PARTS AND COMPONENTS THEREOF

24- Section 7 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
24- EXCESSIVE TEMPERATURES
24- FIRE PREVENTION
25- OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, CLEANING, STERILIZATION AND DISINFECTION
25- PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE
25- HUMAN ERRORS
25- ELECTROSTATIC CHARGES
25- MATERIAL IN APPLIED PARTS IN CONTACT WITH THE BODY OF THE PATIENT
25- INTERRUPTION OF THE POWER SUPPLY

26- Section 8 ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
26- ACCURACY OF OPERATING DATA
26- PROTECTION AGAINST HAZARDOUS OUTPUT

27- Section 9 ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
27- ABNORMAL OPERATION AND FAULT CONDITIONS
27- ENVIRONMENTAL TESTS

28- Section 10 CONSTRUCTIONAL REQUIREMENTS
28- GENERAL
28- ENCLOSURES AND COVERS
28- COMPONENTS AND GENERAL ASSEMBLY
28- MAINS PARTS, COMPONENTS AND LAYOUT
29- PROTECTIVE EARTHS - TERMINALS AND CONNECTIONS
30- CONSTRUCTION AND LAYOUT

44- ANNEX AA SPECIAL NATIONAL CONDITIONS
45- ANNEX BB BIBLIOGRAPHY
46- ANNEX CC RATIONALE
49- ANNEX ZA CLAUSES OF THIS EUROPEAN STANDARD ADDRESSING ESSENTIAL REQUIREMENTS OR OTHER PROVISIONS OF EU DIRECTIVES.
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